ObesityNCT06994780
Lung Ultrasound Evaluation of the Effects of PEEP and Recruitment Strategies Adjusted for Intraoperative Dynamic Compliance on Postoperative Respiratory Complications in Obese Patients Planned for Laparoscopic Surgery
A study testing dynamic compliance guided PEEP titration in people with Obesity and Postoperative Bariatric Surgery, run by Marmara University Pendik Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of the personalized application of respiratory pressures applied to patients undergoing laparoscopic bariatric surgery when they are connected to a ventilator under general anesthesia, on the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Postoperative Bariatric Surgery, Laparoscopic Surgery
- What is being tested?
- dynamic compliance guided PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18, with a body mass index of 35 and above, and who are scheduled for laparoscopic bariatric surgery will be included in our study.
Who cannot join
- Patients with advanced COPD,
- Patients with a history of pneumothorax,
- Patients with lung bullae,
- Patients who have undergone thoracic surgery,
- Patients with a diagnosis of major cardiac disease (valve diseases, heart failure, systolic dysfunction),
- Patients with severe respiratory failure,
- Patients with previous pulmonary surgery will not be included in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University Pendik Training and Reseach Hospital
Istanbul, Pendik
Marmara University Pendik Training and Research Hospital
Istanbul, pendik
About this study
Official title: Lung Ultrasound Evaluation of the Effects of Positive End-Expiratory Pressure (PEEP) and Recruitment Strategies Adjusted for Intraoperative Dynamic Compliance on Postoperative Respiratory Complications in Obese Patients Planned for Laparoscopic Surgery
This study aims to investigate the effects of the personalized application of respiratory pressures applied to patients undergoing laparoscopic bariatric surgery when they are connected to a ventilator under general anesthesia, on the postoperative period. The effects of the ventilation practices that are fixed in routine practice and revised according to various variables during the surgery during artificial respiration after intubation under general anesthesia will be examined with ultrasonography. No change will be made to the routine anesthesia practice for this purpose, the pressure values in the ventilator under general anesthesia will be adjusted during the surgery within the framework of the values used in anesthesia practice. After the surgery, the lung area will be examined with ultrasound in the recovery unit and the findings will be recorded. This study does not have any undesirable effects or risks. This study does not include any interventional procedures.
Read the detailed description
Our study is a double-blind study and the specialist physician performing the postoperative lung ultrasound will not know which group the patient is in. Before the patients are taken into surgery, they will be determined by a permanent anesthesiologist in the preoperative evaluation room using the closed envelope method. The teams that perform all measurements and randomize the patients will remain constant throughout the study. Patients who agree to participate in the study will undergo standard monitoring (heart rate - HR, peripheral oxygen saturation - SpO2, noninvasive blood pressure - NIBP, end-tidal carbon dioxide pressure - etCO2) followed by anesthesia induction. After endotracheal intubation, patients will begin to breathe with volume-controlled ventilation-VCV mode.
In the first group (group PEEP8), a tidal volume of 6-8 ml/kg will be adjusted according to their ideal weight and a fixed PEEP of 8cmH20 will be applied throughout the intraoperative period, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated. The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While applying PEEP titration to patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals so that the maximum peak pressure is 45 cmH2O and the driving pressure is 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained. The spO2 values of the patients in both groups will be targeted as 92-94%, the EtCO2 values as 35-45 cmH2O, and the FiO2 and respiratory rate will be adjusted accordingly. After extubation, the patient will be taken to the recovery room and monitored. After 15 minutes, lung ultrasound (USG) will be performed on patients in both groups by an experienced anesthesiologist who is blinded to the study using the MyLab ™ Seven convex probe (2-5 MHz). Both hemithoraxes will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated for lung sliding movement, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated using the modified lung ultrasound score will be recorded and compared.
- Conditions
- Obesity, Postoperative Bariatric Surgery, Laparoscopic Surgery, Individualized PEEP Treatment Strategy
- Being tested
- dynamic compliance guided PEEP titration
- Keywords
- individualized PEEP treatment surgery, obesity, postoperative pulmonary complications, laparoscopic surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic compliance guided PEEP titrationProcedure or surgery
In order to find the individualized optimal PEEP value, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O. Recruitment will be performed. When the target is reached, the PEEP value will be adjusted to the value at which the highest dynamic compliance is achieved by decreasing it.
| Study group | Role | What they receive |
|---|---|---|
| group PEEP8 | No intervention | The first group (group PEEP8) will be applied with a fixed PEEP of 8cmH20 throughout the intraoperative period by adjusting the tidal volume of 6-8 ml/kg according to the ideal weight, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated. |
| group DC | Experimental | The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While PEEP titration is applied to the patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained. Receives: Procedure: dynamic compliance guided PEEP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified lung ultrasound score
Each hemithorax will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated in terms of lung sliding motion, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated for 12 regions will be recorded and compared using the scoring system defined by Monastesse et al (2017).
Measured: At the end of the surgery, a modified lung ultrasonography will be performed in the recovery unit.
Secondary outcomes (3)
postoperative pulmonary complications
Patients will be visited daily during the postoperative period and evaluated for oxygen need, non-invasive CPAP need, saturation values, pneumonia, shortness of breath, and respiratory distress.
Measured: postoperative 3 days
hospitalization day
The number of days postoperatively, the number of days spent in intensive care or in the patient room will be recorded.
Measured: postoperative day 1-8
postoperatif blood result
Postoperative white blood cell, neutrophil, CRP, creatine values will be recorded.
Measured: postoperative day 1 to 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilara gocmen, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994780
- Sponsor's protocol ID
- Marmara üniversitesi
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared once enough data has been accumulated.
Publications
Gocmen D, Masatlioglu Y, Ozaltun F, Gunal O, Umuroglu T. Does Dynamic Compliance-Guided PEEP Titration Reduce Postoperative Pulmonary Aeration Loss in Laparoscopic Bariatric Surgery? Randomized Controlled Trial. J Clin Med. 2026 May 22;15(11):4018. doi: 10.3390/jcm15114018.
PubMed 42278880
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Evaluation of the Effects of Positive End-Expiratory Pressure (PEEP) and Recruitment Strategies Adjusted for Intraoperative Dynamic Compliance on Postoperative Respiratory Complications in Obese Patients Planned for Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06994780
- Acronym / sponsor ID
- Marmara üniversitesi
- Conditions
- Obesity, Postoperative Bariatric Surgery, Laparoscopic Surgery, Individualized PEEP Treatment Strategy
- Keywords
- individualized PEEP treatment surgery, obesity, postoperative pulmonary complications, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of the personalized application of respiratory pressures applied to patients undergoing laparoscopic bariatric surgery when they are connected to a ventilator under general anesthesia, on the postoperative period. The effects of the ventilation practices that are fixed in routine practice and revised according to various variables during the surgery during artificial respiration after intubation under general anesthesia will be examined with ultrasonography. No change will be made to the routine anesthesia practice for this purpose, the pressure values in the ventilator under general anesthesia will be adjusted during the surgery within the framework of the values used in anesthesia practice. After the surgery, the lung area will be examined with ultrasound in the recovery unit and the findings will be recorded. This study does not have any undesirable effects or risks. This study does not include any interventional procedures.
Detailed description
Our study is a double-blind study and the specialist physician performing the postoperative lung ultrasound will not know which group the patient is in. Before the patients are taken into surgery, they will be determined by a permanent anesthesiologist in the preoperative evaluation room using the closed envelope method. The teams that perform all measurements and randomize the patients will remain constant throughout the study. Patients who agree to participate in the study will undergo standard monitoring (heart rate - HR, peripheral oxygen saturation - SpO2, noninvasive blood pressure - NIBP, end-tidal carbon dioxide pressure - etCO2) followed by anesthesia induction. After endotracheal intubation, patients will begin to breathe with volume-controlled ventilation-VCV mode.
In the first group (group PEEP8), a tidal volume of 6-8 ml/kg will be adjusted according to their ideal weight and a fixed PEEP of 8cmH20 will be applied throughout the intraoperative period, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated. The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While applying PEEP titration to patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals so that the maximum peak pressure is 45 cmH2O and the driving pressure is 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained. The spO2 values of the patients in both groups will be targeted as 92-94%, the EtCO2 values as 35-45 cmH2O, and the FiO2 and respiratory rate will be adjusted accordingly. After extubation, the patient will be taken to the recovery room and monitored. After 15 minutes, lung ultrasound (USG) will be performed on patients in both groups by an experienced anesthesiologist who is blinded to the study using the MyLab ™ Seven convex probe (2-5 MHz). Both hemithoraxes will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated for lung sliding movement, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated using the modified lung ultrasound score will be recorded and compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group PEEP8 | No intervention | –The first group (group PEEP8) will be applied with a fixed PEEP of 8cmH20 throughout the intraoperative period by adjusting the tidal volume of 6-8 ml/kg according to the ideal weight, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated. |
| group DC | Experimental | Procedure: dynamic compliance guided PEEP titrationThe second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While PEEP titration is applied to the patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18, with a body mass index of 35 and above, and who are scheduled for laparoscopic bariatric surgery will be included in our study.
Key exclusion criteria (7 listed)
- Patients with advanced COPD,
- Patients with a history of pneumothorax,
- Patients with lung bullae,
- Patients who have undergone thoracic surgery,
- Patients with a diagnosis of major cardiac disease (valve diseases, heart failure, systolic dysfunction),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic compliance guided PEEP titrationIn order to find the individualized optimal PEEP value, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O. Recruitment will be performed. When the target is reached, the PEEP value will be adjusted to the value at which the highest dynamic compliance is achieved by decreasing it. | Procedure or surgery | group DC |
Primary outcome
Modified lung ultrasound score
Time frame: At the end of the surgery, a modified lung ultrasonography will be performed in the recovery unit.
Each hemithorax will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated in terms of lung sliding motion, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated for 12 regions will be recorded and compared using the scoring system defined by Monastesse et al (2017).
3 secondary outcomes
postoperative pulmonary complications
Time frame: postoperative 3 days
hospitalization day
Time frame: postoperative day 1-8
postoperatif blood result
Time frame: postoperative day 1 to 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Derived from this study: PubMed 42278880Gocmen D, Masatlioglu Y, Ozaltun F, Gunal O, Umuroglu T. Does Dynamic Compliance-Guided PEEP Titration Reduce Postoperative Pulmonary Aeration Loss in Laparoscopic Bariatric Surgery? Randomized Controlled Trial. J Clin Med. 2026 May 22;15(11):4018. doi: 10.3390/jcm15114018.
- This study shows that LUS is highly feasible and frequently detects postoperative pulmonary complications after major abdominal surgery.Link provided by the sponsor.
- Individual participant dataSharing planned: No. It will be shared once enough data has been accumulated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic compliance guided PEEP titration in people with Obesity and Postoperative Bariatric Surgery, run by Marmara University Pendik Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified lung ultrasound score (time frame: At the end of the surgery, a modified lung ultrasonography will be performed in the recovery unit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.